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    Clinical Trial Results:
    A Phase 3 Open-label, Multicenter, Pharmacokinetics, Safety, and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Children with Hemophilia B

    Summary
    EudraCT number
    		 2011-006032-23
    Trial protocol
    		 AT   ES   CZ   IT  
    Global end of trial date
    05 Oct 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    21 Apr 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor clarifications made

    Trial information

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    Trial identification
    Sponsor protocol code
    CSL654_3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01662531
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Behring GmbH
    Sponsor organisation address
    Emil-von-Behring Strasse 76, Marburg, Germany, 35041
    Public contact
    Clinical Trial Disclosure Manager, CSL Behring, clinicaltrials@cslbehring.com
    Scientific contact
    Clinical Trial Disclosure Manager, CSL Behring, clinicaltrials@cslbehring.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001107-PIP01-10
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the pharmacokinetics (PK) of a single dose of rIX-FP. • To evaluate the safety of rIX-FP with respect to the development of inhibitors to Factor IX (FIX) in patients with severe hemophilia B (FIX: ≤ 2%).
    Protection of trial subjects
    To ensure the safety of the subjects, this study did not start until after 50 exposure days (EDs) were accrued in at least 10 subjects ≥12 years of age in the rIX-FP clinical program. Study enrollment was limited to subjects 6 to <12 years of age with at least 150 EDs to previous FIX products and subjects <6 years of age with at least 50 EDs to previous FIX products. Subjects with a history (including family history) of inhibitors against FIX were excluded to further reduce the risk of inhibitor formation during the study. This study was carried out in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice guidelines, the Declaration of Helsinki (2008), and standard operating procedures for clinical research and development at CSL Behring (CSLB). The study protocol and all amendments were approved by the Independent Ethics Committee(s) (IECs) / Institutional Review Board(s) (IRBs) of the participating centers. Before undergoing screening procedures for possible enrollment into the study, subjects and/or their legally acceptable representative were informed, in an understandable form, about the nature, scope, and possible consequences of the study. This information was given orally to subjects by a physician or medically qualified person; written information about the study was also provided in a Subject Information Sheet.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Czech Republic: 3
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Russian Federation: 2
    Worldwide total number of subjects
    27
    EEA total number of subjects
    18
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    3
    Children (2-11 years)
    24
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of the 18 sites that were activated, subjects were enrolled from 17 sites in 10 countries.

    Pre-assignment
    Screening details
    		 Patients <12 years of age with severe hemophilia B (FIX activity of ≤2%) were planned to be enrolled in the study, including 11 to 12 subjects in each age group (6 to <12 years and <6 years of age). Of 29 subjects screened, 27 subjects were enrolled and treated with rIX-FP.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 rIX-FP
    Arm description
    		 All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria. All 27 subjects were included in the Safety, Pharmacokinetic and Efficacy populations.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Recombinant Coagulation Factor IX Albumin Fusion Protein
    Investigational medicinal product code
    CSL654
    Other name
    rIX-FP
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.

    Number of subjects in period 1
    		rIX-FP
    Started
    27
    Completed
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    rIX-FP
    Reporting group description
    		 All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria. All 27 subjects were included in the Safety, Pharmacokinetic and Efficacy populations.

    Reporting group values
    		 rIX-FP Total
    Number of subjects
    		 27 27
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.9 ( 2.93 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 27 27
    Subject analysis sets

    Subject analysis set title
    Age < 6 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.

    Subject analysis set title
    Age 6 to <12 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.

    Subject analysis sets values
    		 Age < 6 Years Age 6 to <12 Years
    Number of subjects
    12
    15
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    3.2 ( 1.7 )
    8.1 ( 1.41 )
    Gender categorical
    Units: Subjects
        Female
    0
    0
        Male
    12
    15

    End points

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    End points reporting groups
    Reporting group title
    rIX-FP
    Reporting group description
    		 All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria. All 27 subjects were included in the Safety, Pharmacokinetic and Efficacy populations.

    Subject analysis set title
    Age < 6 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.

    Subject analysis set title
    Age 6 to <12 Years
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.

    Primary: Incremental recovery following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product

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    End point title
    		 Incremental recovery following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product [1]
    End point description
    Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical PK data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.
    End point type
    Primary
    End point timeframe
    30 minutes after infusion
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were conducted for this end point.
    End point values
    		 rIX-FP Age < 6 Years Age 6 to <12 Years
    Number of subjects analysed
    27 [2]
    12 [3]
    15 [4]
    Units: (IU/dL)/(IU/kg)
    arithmetic mean (standard deviation)
        rIX-FP Assessment (n=27, 12, 15)
    1.0114 ( 0.22711 )
    0.9506 ( 0.20432 )
    1.06 ( 0.23934 )
        Previous FIX Assessment (n=17, 8, 9)
    0.7379 ( 0.19768 )
    0.6764 ( 0.1398 )
    0.7925 ( 0.23219 )
    Notes
    [2] - PK population
    [3] - PK population
    [4] - PK population
    No statistical analyses for this end point

    Primary: Half-life (t1/2) following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product

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    End point title
    		 Half-life (t1/2) following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product [5]
    End point description
    FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.
    End point type
    Primary
    End point timeframe
    Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were conducted for this end point.
    End point values
    		 rIX-FP Age < 6 Years Age 6 to <12 Years
    Number of subjects analysed
    27 [6]
    12 [7]
    15 [8]
    Units: hours
    arithmetic mean (standard deviation)
        rIX-FP Assessment (n=26, 11, 15)
    91.4492 ( 15.9754 )
    89.6124 ( 11.17364 )
    92.7962 ( 19.02537 )
        Previous FIX Assessment (n=16, 7, 9)
    18.6291 ( 6.15551 )
    19.8816 ( 8.01073 )
    17.655 ( 4.52497 )
    Notes
    [6] - PK population
    [7] - PK population
    [8] - PK population
    No statistical analyses for this end point

    Primary: Area under the concentration versus time curve from time point zero to the last sample with quantifiable drug concentration (AUClast)

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    End point title
    		 Area under the concentration versus time curve from time point zero to the last sample with quantifiable drug concentration (AUClast) [9]
    End point description
    AUClast following a single intravenous dose of 50 IU/kg rIXFP or previous FIX product. FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.
    End point type
    Primary
    End point timeframe
    Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were conducted for this end point.
    End point values
    		 rIX-FP Age < 6 Years Age 6 to <12 Years
    Number of subjects analysed
    27 [10]
    12 [11]
    15 [12]
    Units: IU*hr/dL
    arithmetic mean (standard deviation)
        rIX-FP Assessment (n=27, 12, 15)
    4156.704 ( 1204.095 )
    3891.482 ( 1252.994 )
    4368.881 ( 1162.1 )
        Previous FIX Assessment (n=16, 7, 9)
    718.9386 ( 230.5288 )
    676.5414 ( 316.9138 )
    751.9143 ( 146.7045 )
    Notes
    [10] - PK population
    [11] - PK population
    [12] - PK population
    No statistical analyses for this end point

    Primary: Clearance for FIX activity following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product

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    End point title
    		 Clearance for FIX activity following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product [13]
    End point description
    FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.
    End point type
    Primary
    End point timeframe
    Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were conducted for this end point.
    End point values
    		 rIX-FP Age < 6 Years Age 6 to <12 Years
    Number of subjects analysed
    27 [14]
    12 [15]
    15 [16]
    Units: mL/hr/kg
    arithmetic mean (standard deviation)
        rIX-FP Assessment (n=26, 11, 15)
    1.1119 ( 0.31373 )
    1.1841 ( 0.32924 )
    1.0589 ( 0.30203 )
        Previous FIX Assessment (n=16, 7, 9)
    6.4007 ( 2.14434 )
    7.1576 ( 2.78944 )
    5.8119 ( 1.37641 )
    Notes
    [14] - PK population
    [15] - PK population
    [16] - PK population
    No statistical analyses for this end point

    Primary: Number of subjects developing inhibitors to Factor IX (FIX)

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    End point title
    		 Number of subjects developing inhibitors to Factor IX (FIX) [17]
    End point description
    Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.
    End point type
    Primary
    End point timeframe
    12 months
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were conducted for this end point.
    End point values
    		 rIX-FP
    Number of subjects analysed
    27 [18]
    Units: participants
    0
    Notes
    [18] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment-related adverse events

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    End point title
    		 Number of subjects with treatment-related adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 rIX-FP
    Number of subjects analysed
    27 [19]
    Units: participants
        Any adverse event
    26
        Treatment-related adverse event
    0
    Notes
    [19] - Safety Population
    No statistical analyses for this end point

    Secondary: Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis

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    End point title
    		 Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis
    End point description
    For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 rIX-FP Age < 6 Years Age 6 to <12 Years
    Number of subjects analysed
    27 [20]
    12 [21]
    15 [22]
    Units: bleeding episodes
        1 infusion
    94
    40
    54
        2 infusions
    9
    5
    4
        > 2 infusions
    3
    0
    3
        1 or 2 infusions
    103
    45
    58
    Notes
    [20] - Efficacy Population
    [21] - Efficacy Population
    [22] - Efficacy Population
    No statistical analyses for this end point

    Secondary: Consumption of rIX-FP during routine prophylaxis

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    End point title
    		 Consumption of rIX-FP during routine prophylaxis
    End point description
    Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 rIX-FP Age < 6 Years Age 6 to <12 Years
    Number of subjects analysed
    27 [23]
    12 [24]
    15 [25]
    Units: IU/kg/month
        arithmetic mean (standard deviation)
    205.071 ( 41.155 )
    213.517 ( 44.3848 )
    198.314 ( 38.5693 )
    Notes
    [23] - Efficacy Population
    [24] - Efficacy Population
    [25] - Efficacy Population
    No statistical analyses for this end point

    Secondary: Number of subjects developing antibodies against rIX-FP

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    End point title
    		 Number of subjects developing antibodies against rIX-FP
    End point description
    Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 rIX-FP
    Number of subjects analysed
    27 [26]
    Units: participants
    0
    Notes
    [26] - Safety Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    Treatment-emergent AEs (TEAEs), defined as AEs present prior to the first dose of rIX-FP that subsequently worsened in severity or those that were not present prior to the first dose but subsequently appeared are summarized.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    rIX-FP
    Reporting group description
    		 All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study. Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.

    Serious adverse events
    		 rIX-FP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 27 (14.81%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tongue injury
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthralgia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Groin pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 rIX-FP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 27 (85.19%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    9
    Injury
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    4
    Head injury
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    9 / 27 (33.33%)
         occurrences all number
    14
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Gastrointestinal disorders
    Dental discomfort
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    4
    Oropharyngeal pain
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    6
    Bronchitis
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    4
    Ear infection
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    4
    Gastroenteritis
         subjects affected / exposed
    3 / 27 (11.11%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    3
    Viral infection
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    3
    Molluscum contagiosum
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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